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Content Library & Expert specializations cover all sub-industries and functions within Medical Device

GMP/GDP

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Design Controls

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Computer System Validation

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ISO 14971

Design History File

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Complaint Handling

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FDA 483s

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ISO 13485

Registration & Approval Process

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Equipment Calibration

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CAPA

R

Quality Risk Management

h

FMEA

Supplier Management

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Root Cause Analysis

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21 CFR

International Regulation BRIC/Japan/LATAM

Q

Quality Agreements

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Cleaning & Labelling

f

510K

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DHFs, DMRs, and DHRs

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Audit & Inspections

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Technical Writing/SOPs

Contract Manufacturing

CE marks

Mobile Medical APPs

Import Requirements

Maintenance & Validation

Social Media Compliance

Post Market Surveillance

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Some of the most popular Expert Led Content in FDA & Medical Device

Medical Device

Understanding and Implementing a Practical Quality by Design Program

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Medical Device

Unique Device Identifier(UDI) Implementation

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Medical Device

Medical Writing: study protocol, informed consent, adverse events reports, etc.

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Medical Device

Reprocessing Reusable Medical Devices – Cleaning & Labeling Requirements

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Medical Device

Environmental Monitoring – Setting Accurate Alert and Action Limits

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Medical Device

Writing Effective IQ, OQ, PQ Protocols for Equipment Qualifications

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Medical Device

Verification vs. Validation in Regulated Industries

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Medical Device

Streamlining your Internal Auditing Program for FDA and ISO 13485 Compliance

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Medical Device

Understanding and Implementing a Practical Technology Transfer Process

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Medical Device

The Use and Misuse of FMEA in Medical Device Risk Management

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Medical Device

Design Control for Professionals

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Medical Device

FDA’s Medical Device Software Regulation & Compliance //FDA’s Current Change in Software Regulation and Future Cybersecurity Concerns for Digital Health Functions

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Medical Device

Performing Effective and Compliant Sterility Failure Investigations

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Medical Device

Corrective & Preventive Action Explained

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Medical Device

Demonstrated Techniques to a Successful 510k Submission / (PL Title)Keys to a Successful 510k Submission

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